MAUDE Adverse Event Report: CORDIS US CORP SUPER TORQUE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	533551
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the white tip of a 5.2f judkins left 3.5 (jl3.5) super torque plus diagnostic catheter broke.There was no reported patient injury.Per preliminary image review, pictures of the device show that the hub of the catheter was broken into separate pieces.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
The device was returned for evaluation.
Additional Manufacturer Narrative
As reported, the white tip (luer hub) of a 5.2f judkins left 3.5 (jl3.5) super torque plus diagnostic catheter broke.There was no reported patient injury.A non-cordis catheter was used as replacement.The white tip was identified as the luer hub, described as the main entry point for wires that pass through the catheter.The use of a contralateral approach remains unknown.The patient was not hospitalized due to the event, nor was their hospitalization extended.Per preliminary image review, pictures of the device show that the hub of the catheter was broken into separate pieces.A non-sterile catheter (cath f5.2+ jl3.5 100 cm) was received coiled inside a clear plastic bag along with fragments of the hub in a plastic container.Visual inspection confirmed the hub was separated/cracked, with no additional anomalies observed on the device components.Amplified and sem imaging were performed on the hub area.The sem analysis revealed fatigue striations and plastic deformation consistent with tensile overload, indicating that the material was subjected to forces exceeding its yield strength prior to failure.No other structural, material, or manufacturing anomalies were identified during the evaluation.A product history record (phr) review of lot 18436018 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The malfunction ¿luer hub ¿ separated¿ was observed during the product evaluation.The exact cause of the event cannot be determined; however, handling factors cannot be ruled out as a potential contributor since signs of mechanical interaction or stress were observed.The information provided does not indicate whether the device was used according to instructions; however, users are trained to inspect for signs of damage prior to and during use.Based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18436018 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SUPER TORQUE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 22853866
• Report Number: 9616099-2025-01352
• Device Sequence Number: 17265302
• Product Code: DQO
• UDI-Device Identifier: 10705032012669
• UDI-Public: (01)10705032012669(17)280331(10)18436018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 533551
• Device Lot Number: 18436018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 09/17/2025; 10/03/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/10/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown